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FDA Continues to Confirm Antidepressant Risks I First Identified More Than a Decade Ago


In 2004 the FDA issued a black box warning about the increased risk of suicidality in children taking the newer antidepressants, including the SSRIs (Prozac, Zoloft, Paxil, Luvox, Celexa, and Lexapro) and also Effexor and Wellbutrin (also marketed as Zyban). On June 30, 2005 the FDA published a Public Health Advisory warning of the possibility of increased suicidality in adults treated with antidepressants. The FDA followed this on July 1, 2005 with a Talk Paper elaborating on the potential risk and the agency's plans to study the problem further. All of these FDA documents are available on www.fda.gov.

The FDA should have issued these warnings at least a decade ago. I first began writing about antidepressant-induced suicidality in 1991. At that time I identified drug-induced suicidality as part of a much larger problem -- antidepressant-induced activation or stimulation similar to that caused by amphetamine, methamphetamine and cocaine. Antidepressant stimulation can lead to violence as well as suicide and a wide variety of abnormal and even psychotic behaviors.

Prozac was introduced to the American public in January 1988. Three years later in my book Toxic Psychiatry (St. Martin's Press, New York, 1991) was published. In that book, as well as in many later books and scientific articles, I made the following points:

All of the newer antidepressants can stimulate the brain. The results of stimulation are similar to the effects of amphetamine, methamphetamine, methylphenidate, and cocaine. Stimulating the brain leads to anxiety, agitation, irritability, insomnia, disinhibition (loss of self-control), emotional lability (instability), akathisia (agitation with hyperactivity), hostility, aggression, and mania.

Especially in people who are already depressed, these over-stimulated reactions can lead to a severe worsening of depression or to transformation of the depression into mania. These effects can cause suicide and violence toward others.

After I described the risk of antidepressant-induced stimulation in 1991, I further developed the concept in subsequent books, including Talking Back to Prozac (1994), Brain-Disabling Treatments in Psychiatry (1997), Your Drug May Be Your Problem (1999, with David Cohen) and the Antidepressant Fact Book (2001). I have also testified to the same principles in numerous malpractice, product liability, and criminal cases involving antidepressant-caused suicidality, violence, and varied severe abnormal behaviors. Long before the FDA came around to agreeing with me, the courts have found sufficient scientific merit to my arguments to allow them to be expressed at trials, including product liability cases against the manufacturers of these drugs. The vast majority of these cases against drug companies were settled before going to trial.

Shortly before the FDA met in 2004 to consider antidepressant-induced suicidality in children, I wrote a peer-reviewed scientific article that was simultaneously published in Ethical Human Sciences and Services and the International Journal of Risk and Safety in Medicine (available on www.breggin.com). My paper drew together all of the available scientific evidence that the newer antidepressants cause a stimulant or activation syndrome that can drive a person toward suicide or murder. I used scientific concepts and language in this paper that were subsequently adopted by the FDA:

"Mania with psychosis is the extreme end of a stimulant continuum that often begins with lesser degrees of insomnia, nervousness, anxiety, hyperactivity and irritability and then progresses toward more severe agitation, aggression, and varying degrees of mania." (Breggin 2003/4, p.. 32; obtainable on www.breggin.com).

I also discussed in detail the risk of akathisia (agitation with hyperactivity) as a cause of violence and suicide.

On March 22, 2004 the FDA published a Talk Paper entitled, "FDA Issues Public Health Advisory on Cautions for the Use of Antidepressants in Adults and Children." The advisory focused on adults as well as children and stated:

"The agency is also advising that that these patients be observed for certain behaviors that are known to be associated with these drugs, such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania."

This FDA statement is interchangeable with many that I have made in the literature and in the courtroom.

The FDA describes these adverse reactions as "known"--that is, scientifically demonstrated or established. The list confirms the existence of the antidepressant-induced stimulant effect or activation syndrome in adults and children with its potential to cause hostility and related behaviors. The FDA has gone on to require drug manufacturers to include these antidepressant-induced adverse effects in their FDA-approved labels for the drugs. The FDA label for antidepressants (revised January 26, 2005) requires the following statement about activation or stimulation in children and adults:

"The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as other indications."

Simultaneously, the FDA compelled the drug companies to include a specific warning about the increased risk of suicidality in children taking antidepressants. This warning has received the most attention in the media and the medical profession. However, FDA recognition of the stimulant or activation syndrome, including the production of increased agitation, irritability, impulsivity, hostility, aggressiveness, and mania is in many ways more important. Over-stimulation is far more common than suicidality and causes not only suicidality but also violence and an endless variety of destructive, impulsive behaviors.

The adverse effects described by the FDA are almost identical to mine, suggesting that they paid attention to my publications and to my testimony before the agency on two occasions in 2004 (obtainable on www.breggin.com). Also, the FDA's has followed my method of organizing these specific adverse effects into one group that can be viewed as stimulation or activation. I have written in some detail about the implications of recent regulatory changes in regard to antidepressants that have occurred in the U.S., Canada and Great Britain.


The FDA has continued to affirm the points I first made in 1991 in Toxic Psychiatry. On June 30, 2005, the FDA issued another Public Health Advisory, this time aimed more specifically at adults, entitled, "Suicidality in Adults Being Treated with Antidepressant Medications." The FDA announced the beginning of a lengthy review of the subjected and in the meanwhile warned:

"Adults being treated with antidepressant medications, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior."

On July 1, 2005 the FDA issued an FDA Talk Paper on the same subject. It emphasized another point that I have been making in my books and articles, and in court, for many years:

"Close observation of adults may be especially important when antidepressant medications are started for the first time or when doses for the specific drugs prescribed have been changed."

I have been consulted in dozens of malpractice and product liability cases in which patients have committed suicide or perpetrated violence against others shortly after starting antidepressants or shortly after dose changes.

Naturally, it is gratifying to have the scientific literature and the FDA confirm observations that I have made, at some professional cost, for many years. It is satisfying to see views once labeled radical and controversial become centerpieces of establishment drug regulation. On the other hand, it is frustrating and even tragic that there has been such a long delay in coming to grips with drug-induced problems that have resulted in innumerable acts of suicide and violence. Furthermore, medical professionals, especially my colleagues in psychiatry, continue to resist and even to ignore the scientific evidence and the warnings from the FDA. The FDA itself has shown no willingness to take the next step--to ban these largely ineffective and highly dangerous agents.


Dr. Breggin's latest book is Medication Madness: A Psychiatrist Exposes the Dangers of Mood-Altering Medications (2008) and his revised and updated website is Breggin.com.